Announcement of fda approval perla®

Spineart announces that it has recently received 510(k) clearance from the U.S. FDA to market the PERLA® posterior cervico-thoracic fixation system. The system is intended for stabilization of spinal segments as an adjunct to fusion of the cervical spine (C1 to C7) and the thoracic spine (T1 to T3). PERLA® features a comprehensive implant range including preferred angle lateral mass and smooth shank screws, as well as nine different types of connectors for greater flexibility intraoperatively. Transitional rods (CoCr or Titanium) are available to extend the construct to the lumbar spine. In accordance with the Spineart philosophy, the instrument set is ultra-compact and features multi-functional instruments.

All Spineart implants, including the entire PERLA® range, are sterile packed and barcoded for increased safety, procedure compliance and cost-efficiency. For additional product information and distribution opportunities, please contact us at contact@spineart.us.